WO2003032820A1 - Speculum vaginal a lames amovibles - Google Patents
Speculum vaginal a lames amovibles Download PDFInfo
- Publication number
- WO2003032820A1 WO2003032820A1 PCT/US2001/043958 US0143958W WO03032820A1 WO 2003032820 A1 WO2003032820 A1 WO 2003032820A1 US 0143958 W US0143958 W US 0143958W WO 03032820 A1 WO03032820 A1 WO 03032820A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- vaginal speculum
- speculum
- respect
- vagina
- vaginal
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/32—Devices for opening or enlarging the visual field, e.g. of a tube of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/303—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for the vagina, i.e. vaginoscopes
Definitions
- the present invention relates to medical diagnostic instruments, in particular to a vaginal speculum for visual examination of the vaginal cavity, vaginal walls, and conditions of the cervix.
- a vaginal speculum is a diagnostic instrument for dilating the opening of the vagina cavity in order that the interior may be more easily visible for observation.
- a vaginal speculum has two expandable blades, which are inserted into the vagina in a closed state and then expanded, or moved apart for dilating the vaginal cavity.
- a vaginal speculum is an indispensable instrument not only for gynecologists but also for primary care physicians, geriatricians, urologists, and nurse practitioners for urological examination of patients suffering from urinary incontinence in order to exclude the presence of vaginal prolapses, such as rectocele, cystocele, enterocele, and uterine prolapse.
- Vaginal prolapses of the aforementioned type are protrusions or herniation of the urethra or other pelvic organs into the vagina.
- the instrument consists of three parts of molded non-toxic plastic materials, i.e., a fixed member, a movable member, and a sliding member.
- the sliding member is slidingly installed in the fixed member and pivotally supports the movable member so that the movable member can be rotated around the pivot at the proximal end of the fixed member.
- the distal ends of the movable and fixed members which form expandable blades insertable into the vagina, can dilate the vagina cavity and thus allow internal vaginal observations.
- the members are made from a transparent plastic and the blades form a thin-wall circular or oval cross-section, which allows the observation.
- a procedure of examination of a vagina with the use of a speculum involves movements of the speculum in an expanded, i.e., an outwardly diverging state in the direction towards or away from the uterus. This is necessary for diagnosing aforementioned vaginal prolapses.
- the opening of the vagina has a circular muscle, which is more resistant to dilations than the vaginal cavity, the aforementioned withdrawal of the expanded speculum may cause in patient discomfort and painful sensations. This is because in the course of the withdrawal of the speculum the diameter of its portion at the vaginal opening is stretched by the speculum.
- the conventional vaginal specula do not have features for measuring the length of vagina and for testing and measuring the severity of the prolapses without completely removing the entire speculum.
- the physician disassembles the speculum and inserts only one of the blades for pressing on one wall of the vagina for exposing and observing the opposite wall.
- a separate ruler is used for measuring the length and position of the prolapse or prolapses. The procedure is then repeated for expositing the opposite wall of the vagina cavity.
- the physician uses a separate single metal blade for pressing on the anterior and posterior walls of the vagina cavity.
- the examination involves the use of several tools, as well as assembling and disassembling operations.
- a papiloma is a growth pattern of epithelial tumors.
- Another object is to provide the aforementioned vaginal speculum with features that allow complete disconnection of one of the blades without removal of the entire speculum from the patient's vagina.
- Still another object is to provide a method for measuring positions and severity of vaginal prolapses and for performing other vaginal measurements with the use of the vaginal speculum having removable blades with scales.
- Fig. 1 is a side sectional elevation view of the speculum of the invention.
- Fig. 2 is a sectional view along line ll-ll in Fig. 1.
- Fig. 3 is a view of the vaginal speculum of Fig. 1 , which shows the blades of the speculum in an open or expanded position.
- Fig. 4 is a sectional view along line IV-IV in Fig. 3.
- Fig. 5 is a rear view of the vaginal speculum of the invention in the direction of arrow A in Fig. 1.
- Fig. 6 is a side sectional elevation view of the speculum according to another embodiment of the invention, in which both blades are adjustable.
- Fig. 7 is a sectional view along line VII-VII in Fig. 6.
- Fig. 8 is a view in the direction of arrow B in Fig. 6.
- Fig. 9 is a view in the direction of arrow C in Fig. 6.
- Fig. 10 illustrates another embodiment of the speculum of the invention in which the handle portion is bent backward to form an obtuse angle with the longitudinal direction of the adjustable blades.
- Fig. 11 shows another embodiment of the speculum of the invention in which the proximal ends of the adjustable blades are bent radially outward from the longitudinal axis of the adjustable blades.
- Figs. 12 and 13 are fragmental views in the direction of arrows D and E of Fig. 6, respectively.
- Fig. 14 is a partial side view of a vaginal speculum in accordance with another embodiment of the invention.
- Fig. 15 is a sectional view of normal reproductive organs of a woman.
- Fig. 16 shows an example of cystocele inside the vaginal canal.
- Fig. 17 shows a condition of a cystocele protruding outside the vagina.
- a vaginal speculum consisting of two blades pivotally interconnected through a fork-like member so that the blades can be expanded and fixed in an expanded state in order to dilate the vagina for observing the condition of the vagina cavity.
- the device is characterized by having adjustable blades, which can be withdrawn partially or completely for replacement with blades of other dimensions without withdrawing the entire speculum from the vagina. In a closed state, the distal ends of the blades form a bifocal lens, which can be used for visually detecting changes, associated with an earlier stage of cancer or erosion. Provision of retractable blades makes it possible for a physician to withdraw the blades in an alternating sequence for exposing one of the walls of the vagina cavity by pressing down with the longer blade on the opposite wall.
- one of the blades in order to expose the vaginal wall for improving observation conditions, one of the blades can be completely disconnected without removing the entire speculum from the vagina. The remaining blade can be used as a spade for pressing on the opposite wall of the vagina.
- vaginal speculum of the present invention is similar to the one described in US Patent No. 3,716,047 and is aimed at its improvement, as well as at an improvement of any other vaginal speculum of the type having two blades which are expanded by rotating around a pivot at their proximal ends.
- the speculum 20 comprises a fixed blade member 22, a slide member 24, and a movable blade member 26.
- the fixed blade member 22 has an L-shaped configuration with a blade portion 22a insertable into the patient's vagina, and a handle portion 22b substantially perpendicular to the blade portion 22a.
- the blade portion 22a is hollow and, as can be seen from Fig. 2, which is a sectional view along line II- II in Fig. 1, it has a semicircular cross-section.
- the distal end of the blade portion 22a i.e., the end opposite to the handle portion 22a, has a half-lens 25, which is formed, e.g., molded, integrally with the remaining part of the blade portion 22a.
- the half-lens 25, in fact, is a portion of a biconvex lens obtained by cutting a lens by half along an optical axis X-X (Fig. 1).
- Fig. 3 is a view of the vaginal speculum 20 of the invention, which shows the blades of the speculum of Fig. 1 in an open or expanded position.
- Ratchet teeth 30 are formed on the lower rear side of the handle portion 22b for the purposes explained later. As shown in Fig. 4, which is a sectional view along line IV-IV in Fig. 3, the part of the handle portion 22a located above the teeth 30 may have a slot 32 of a T-shaped cross-section for guiding a complementary shaped part of the slide member 24, which also has a T- shaped cross-section.
- the slide member 24 of the vaginal speculum 20 of the present invention has a fork-like straight portion 34, a rearward projection 36 which is substantially perpendicular to the straight portion 34 and has teeth 38 on one of its sides, and a tail portion 40 with a pawl 42 for engagement with ratchet teeth 30.
- Fig. 5 is a rear view of the vaginal speculum 20 of the invention in the direction of arrow A in Fig. 1.
- the fork-like portion 34 of the slide has holes 44 and 46 on the inner sides of fork legs 34a and 34b. These holes receive projections 43 and 45 formed on the outer side walls of proximal part of the movable member 26.
- the movable member 26 can perform rotating or swinging movements around projections 43 and 45 as pivot points.
- the movable member 26 has an L-shaped configuration (Fig.
- the insertable blade portion 26a of the moveable member 26 is symmetrical to the insertable blade portion 22a of the fixed member 22 and is complementary thereto so that in a closed state of the speculum 20 shown in Fig. 1 both blade portions form a substantially round cross section.
- the blade portion 26 has a semicircular or oval cross-section shown in Fig. 2 and has a half-lens 48 with a flat surface 50 (Fig. 3).
- the blade portions 22 and 26 in a closed state of the speculum, form a tubular body of a complete round or oval cross-section with a complete biconvex lens formed by two half-lenses 25 and 48 at the distal end of the speculum.
- Reference numeral 52 designates a flat surface on the lens portion 48.
- the movable blade member 26 has, on the inner side, guide edges 26c and 26d.
- guide edges 26c and 26d may be formed only on a short portion (L) of the entire length of the movable member 26.
- the guide edges 26c and 26d are used for slidingly guiding a removable blade 54 (Figs. 1 , 3. and 3) of the moveable member 26.
- moveable member 26 in turn, consists of two parts, i.e., the main part with the trigger portion 26b and the adjustable blade 54, which contains the aforementioned insertable part 26a.
- the adjustable blade 54 may have tight sliding fit in the grooves 26e and 26fr, so that it can be shifted in the rearward direction, i.e., in the direction opposite to the direction of arrow A in Fig. 1 , to assume a position shown in Fig. 3.
- the adjustable blade 54 may have a tab 55 on its rear end.
- the expansion diameter D2 will be smaller than the expansion diameter D1 for non-adjustable blade member 26 shown in Fig. 3 by the broken line 26'.
- the proximal end of the adjustable blade 54 has a dent 54a on its outer surface, whereas the moveable portion 26 has an indent 26h on its inner surface for engagement with the dent 54a.
- the dent 54a is engaged with the indent 26h under the effect of resiliency of the adjustable blade 54, so that during insertion of the distal end of the speculum 20 into the patient's vagina the adjustable blade will not slide relative the moveable portion.
- the tab 55 will bears up against the thumb of a physician who inserts the speculum.
- trigger portion 26b has an opening 26g with teeth 26k on the solid part of the trigger 26b for engagement with the teeth 38 on the projection 36 (Fig. 1).
- the teeth 26k and 38 may be formed as ratchet teeth and a pawl so that pushing on the trigger 26 in the direction of arrow A will rotate the movable member 26 on pivot projections 43 and 45 for expanding the speculum blades 22 and 26. Due to the ratchet engagement between the teeth 26k and 38, after the trigger is releases, the blades 22 and 26 will remain in the expanded position shown in Fig. 3.
- the adjustable blade 54 can be completely removed and replaced by another blade having a different length.
- Fig. 6 illustrates another embodiment of the vaginal speculum of the invention, in which both blades, i.e., a blade 56a of a movable member 56 and a blade 58a of a fixed member 58 are adjustable.
- the rest of the construction is the same as in the embodiment shown in Figs. 1 through 5.
- Fig. 7, which is a sectional view along line VII-VII in Fig. 6, the fixed member 58 has on the inner side of the blade portion 58a guide edges 58c and 58d.
- guide edges 58c and 58d may be formed only on a short portion (Li) of the entire length of the fixed member 58.
- the grooves 58e and 58f are used for slidingly guiding the adjustable blade 58a (Figs. 6) of the fixed member 58.
- the speculum of Fig. 6 makes it possible to adjust the positions of both adjustable blades 56a and 58a, so that along with the significant decrease in the diameter D 3 (Fig. 6), it becomes possible to ensure painless partial withdrawal of the of the blades in an expanded state for observation of the proximal part of the vagina.
- the proximal end of the adjustable blade 58a has a dent 62a on its outer surface, whereas the fixed member 58 has an indent 58b on its inner surface for engagement with the dent 62a.
- the vaginal speculum of the present invention is additionally provided with means for locating a position of a vaginal prolapse, of both cystocele-type and rectocele type.
- both adjustable blades have on their proximal ends scales, e.g., in centimeters.
- Figs. 8 and 9 are fragmental views in the direction of arrows B and C of Fig. 6, respectively.
- the adjustable blade 56a has a scale 64 with divisions applied onto its outer surface and has the very end as a zero or a reference point with the number in centimeters or inches increased from this point to the proximal end.
- the scale 64 can be used as a conventional ruler.
- a scale 68 has divisions applied onto the inner surface of the blade 58a. The divisions should be made black so that they could be seen on the transparent background of the material of the adjustable blades 56a and 58a.
- the lower scale also has its reference point at the outermost distal point of the adjustable blade 58a.
- Fig. 10 shows another embodiment of the speculum of the invention in which the handle portion 80 can be bent backward to form an obtuse angle ⁇ with the longitudinal direction of the adjustable blades 82 and 84 in order not to interfere with outwardly extending parts of the patient's body, such as buttocks, e.g. in overweight women.
- Fig. 11 shows another embodiment of the speculum of the invention in which the proximal ends 86 and 88 of the adjustable blades 90 and 92 are bent radially outward from the longitudinal axis of the adjustable blades 90 and 92. This is necessary in order not to obscure the vision through the central opening of the speculum when, during expansion of the distal ends of the blades 90 and 92, their proximal ends 86 and 88 move radially inwardly toward each other.
- Figs. 12 and 13 are fragmental views in the direction of arrows D and E of Fig. 6, respectively.
- the scale 64 on the movable or adjustable blade 56a may extend further to the protruding proximal end 60 of the adjustable blade 56a, so that measurements can be read with regard to the rear edge 66 of the movable part 56.
- the same principle can applied to the fixed member 58, where divisions of the scale 68 can extend to the protruding proximal end 72 (Fig. 13), so that measurements can be read with regard to the rear edge 70 of the fixed member 58.
- Fig. 14 is a partial side view of a vaginal speculum in accordance with another embodiment of the invention, in which the pivotally connected parts of the speculum have a completely disconnectable pin and slot connection that allows disconnection of one of the members from the other without removing the entire vaginal speculum from the woman's vagina. Since all other part of this speculum can be the same as those shown in Figs. 1 through 13, only parts different from the previous embodiments are shown and described with reference to Fig. 14. More specifically, the upper end of the fork-like sliding part 126, which is equivalent to the part 34 of Fig.
- FIG. 1 has a hook-like shape with bayonet slots 164, 166 (the slot 166 is formed on the side of the fork-like part which is not seen in Fig. 14) at the point of connection with projections 130, 132 (only projection 130 is shown in Fig. 14) formed on the moveable part 120 (which is equivalent to part 20 in Fig. 1 ) .
- the slots 164 and 166 serve for insertion of the pins 130, 132.
- Arrows C in Fig. 14 show directions of assembling-disassembling of parts 120 and 120.
- Such a construction makes it possible to completely disconnect the upper moveable part 120 from the lower part 122 of the vaginal speculum without removing the entire speculum from the patient's vagina.
- the physician will have conditions for unobstructed observation of one of the vaginal walls and for using the remaining blade as a spade for pressing on the vaginal wall, which is opposite to the exposed one.
- a vaginal speculum of the aforementioned type makes it possible to reduce the number of instruments and to shorten the examination or treatment time. Procedure for the use of the retractable vaginal speculum
- the procedure is started from inspection of the vaginal introitus to determine the status of the vaginal skin, the size of the vaginal outlet, and the presence or absence of pelvic organ prolapse.
- a retractable vaginal speculum of a required size is then chosen.
- a retractable vaginal speculum is normally a disposable instrument, which is sterilized and packed into a sealed package, it is unpacked and removed from the package.
- the insertable ends 26a and 22a of the blade members 22 and 26 are then lubricated using a water-soluble lubricant.
- the insertable ends 26a and 22a of the speculum 20 are then gently inserted into the vaginal canal in a closed state of the speculum 20 shown in Fig. 1 , and are advanced all the way to the vaginal vault or at the level of the uterine cervix 101 , shown in Fig. 15, which is a sectional view of normal reproductive organs of a woman.
- the physician first visually observes the condition of the uterus cervix through the optical lens formed by semi-lenses 48 and 25.
- the purpose of this observation is to detect initial changes on the cervix that could not be detected by a naked eye. Such changes may be initial erosion, papilomas, etc.
- the speculum 20 is then opened by moving the blade members 22 and 26 apart to further visualize the vaginal vault or the cervix. This is done by pushing on the trigger portion 26b so that the teeth 26k slide in a ratchet manner over the teeth 38 of the projection 36. As a result, the blade members 22 and 26 of the speculum assume the positions shown in Fig. 3 and thus expand the vaginal cavity (not shown in the drawings).
- the physician can then observe the appearance of the vaginal mucosa at the level of the vault, or observe the appearance of the cervix.
- the length of the vaginal canal is measured from the vaginal vault or the posterior aspect of the cervico-vaginal junction to the level of the hymenal line. This is achieved by pushing down on the tab 55 (Fig. 3) of the adjustable blade 54 for disengaging the dent 54a from the indent 26h and by moving the adjustable blade 54 to a required position. Measurement is made by reading the numbers of the scale 64 with regard to the hymeneal line, as will be described later. As shown in Figs. 8 and 9, where Fig. 8 is a view in the direction of arrow B, and Fig.
- FIG. 9 is a view in the direction of arrow C in Fig. 6, the divisions of the scale are applied onto the entire length of the blades 54 and 25 in the embodiment of Fig. 1 , and of the blades 54a and 58a in the embodiment of Fig. 6, so that the physician could measure the distance from the hymeneal ring to the cervix, as well as the distance to the end of the prolapse using the very end of the distal end as the reference point for measurement. If necessary, the physician performs paps smear and/or collection of fluids for culture and or cytology as indicated. Slight thickening of the curved end walls on the distal ends of the blades 20 and 22 caused by the formation of semi- lenses does not create any obstacles for this operation.
- the adjustable blade e.g. blade 54 (Figs. 1 and 2) is then retracted halfway so that the blade of the speculum 20 (or speculum 56) is in a position required for the observation of the exposed wall. Since one of the blades, i.e., the blade 22 remain in the initial position (Fig. 3) and another blade, i.e., 26, is partially withdrawn, the physician may observe the condition of the exposed part of the vagina wall for observation and thus to see prolapses on the exposed wall.
- both adjustable blades 56a and 58a can be withdrawn in alternating sequence, or can be retracted both together to see if the uterus or the vaginal vault (dome) will drop further down.
- the degree of the drop of the uterus or the vaginal vault (dome)(if the uterus is gone) in relation to the hymeneal line can be measured with the calibrated retractable blade.
- Fig. 15 shows a normal anatomy of female reproductive organs with the speculum of the invention inserted into the vagina
- Fig. 16 shows an example of cystocele inside the vaginal canal and method for measuring its position and dimensions
- Fig. 17 shows a condition of a cystocele protruding outside the vagina and a method for measuring the length of this cystocele.
- the measuring procedure will be illustrated and described with reference to the embodiment of the vaginal speculum shown in Figs. 1 through 5, the procedure will be the same for vaginal specula with two removable blades and with completely disconnectable parts of the speculum.
- the distance L1 between the tip of the cervix 100 and the hymeneal ring is measured by inserting the speculum 102 in a closed state shown in Fig. 1 to contact with the dome of the uterus 100 and by reading the number on the scales of the blades at the hymeneal line 104.
- the distance between these two points will be in centimeters and will be recorded as a minus number. For example, if the cervix is prolapsing (not shown) and the distance from the edge of the cervix inside the vaginal canal to the hymeneal ring is 3 centimeters, then the cervix prolapse is -3cm.
- the physician can retract the adjustable blade 54 (Fig. 3), or the adjustable blade 56a (Fig. 6), and then move it to contact of the distal tip of this adjustable blade with the edge of the cystocele.
- the distance L1 between with the edge of the cystocele 106, touching the tip of the retractable blade 106, and the level of the hymeneal line 108 is then measured with regard to the hymeneal line 104 as a reference point. If L1 is 4 centimeters, then the prolapsing cystocele is -4cm. The same procedure can be performed with regard to rectocele (not shown) by moving the adjustable blade 58a (Fig. 6).
- the measurement of the prolapse will be a distance L2 from the hymeneal line 112 to the furthest tip of the prolapsing cystocele. This distance is measured by means of the scale on the tip 114 of the speculum 116 as by a conventional ruler. If the prolapse is dropping outside the hymeneal line; i.e. is 5 centimeters, the cystocele prolapse is +5cm.
- the severity and positions of the prolapses can be measured by using rear edges 66 (Fig. 12) and 70 (Fig. 13) of respective proximal portions of the blades.
- the distance L1 can be measured by reading the number on the scale 68 between the edge 70 of the cystocele 106 touching the tip of the retractable blade 106 and between the edge 70 and the hymeneal line 108.
- the length L1 will be determined by subtracting the second reading from the first one. The same is applicable for measuring rectocele (not shown).
- the invention provides a disposable vaginal speculum, which is simple in construction, easy to operate, inexpensive to manufacture, allows painless withdrawal of the speculum blades in an expanded state, has removable blades, provides means for measuring the length of the vagina, allows measuring the severity of the prolapse, provides optical magnification means for enlargement of the observed area, and gives allowance to concentrate the observation separately on each wall of the vagina.
- the vaginal speculum is provided with features that allow complete disconnection of the upper part of the speculum from the lower part without removal of the entire speculum from the patient's vagina.
- the invention provides a method for measuring positions and severity of vaginal prolapses and for performing other vaginal measurements with the use of the vaginal speculum having removable blades with scales.
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
L'invention concerne un spéculum vaginal (20) comprenant deux lames (22, 26) interconnectées de manière pivotante par l'intermédiaire d'un élément (34) du type fourchette, de sorte que lesdites lames peuvent être déployées et maintenues à l'état déployé afin de dilater le vagin pour observer l'état de la cavité vaginale. Ce dispositif est caractérisé en ce que les lames sont réglables (56a, 58a), ce qui permet de les retirer partiellement ou complètement pour les remplacer par des lames d'autres dimensions sans retirer la totalité du spéculum (20) du vagin. A l'état fermé, les extrémités distales des lames (28, 26) forment une lentille bifocale (25, 48) pouvant être utilisée pour détecter visuellement des modifications associées à un stade précoce de cancer ou d'érosion. La mise à disposition de lames rétractables (22, 26) permet à un médecin de retirer lesdites lames (56a, 58a) dans une séquence alternante afin d'exposer l'une des parois de la cavité vaginale par pression de la lame la plus longue vers le bas sur la paroi opposée.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US09/977,029 US6569091B2 (en) | 2000-05-04 | 2001-10-15 | Disconnectable vaginal speculum with removeable blades |
| US09/977,029 | 2001-10-15 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2003032820A1 true WO2003032820A1 (fr) | 2003-04-24 |
Family
ID=25524738
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2001/043958 Ceased WO2003032820A1 (fr) | 2001-10-15 | 2001-11-14 | Speculum vaginal a lames amovibles |
Country Status (2)
| Country | Link |
|---|---|
| US (1) | US6569091B2 (fr) |
| WO (1) | WO2003032820A1 (fr) |
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| DE102009034495A1 (de) * | 2009-07-22 | 2011-01-27 | Christian Bich | Weitungs- und Dehnungsapparatur zur Behandlung von Phimose |
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Also Published As
| Publication number | Publication date |
|---|---|
| US20020022771A1 (en) | 2002-02-21 |
| US6569091B2 (en) | 2003-05-27 |
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